Stapokibart

CHENGDU, China, April 5, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") today announced that the prestigious medical journal Nature Medicine has published the results from the Phase III trial of its independently developed IL-4Rα antibody stapokibart, for the treatment of moderate-to-severe seasonal allergic rhinitis (SAR). The study, led by Professor Luo Zhang of Beijing Tongren Hospital, Capital Medical University, represents the world's first clinical report on an IL-4Rα-targeted biologic for SAR, underscoring Chinese scientists' pioneering role in allergic rhinitis innovation. The study demonstrated that stapokibart significantly alleviates clinical symptoms and improves quality of life in patients with moderate-to-severe SAR who remained inadequately controlled despite standard therapies. This breakthrough offers a transformative solution to a global health challenge, ushering in a new era of biologic treatments for allergic rhinitis and providing hope to hundreds of millions of patients worldwide. Rapid, potent and sustained control of nasal symptoms: Rapid relief of nasal obstruction：Compared to placebo group, patients in stapokibart group achieved significantly greater improvement in nasal congestion symptom at Day 2. By Day 7, 72% of patients reported clear nasal breathing, with the cumulative response rate rising to 86% at Week 2 and 94% at Week 4. Potent and sustained control of nasal symptoms：Stapokibart demonstrated a 2.7-point reduction in daily reflective total nasal symptom score (rTNSS) from baseline by Day 4, significantly greater than the improvement in the placebo group. Over the 2-week treatment period, stapokibart achieved a 3.6-point reduction in daily rTNSS from baseline, with a least squares (LS) mean difference of -1.3 points vs. placebo (the primary efficacy endpoint). Additionally, 62% of patients achieved mild or no symptom (defined as rTNSS ≤1 point for each symptom); Over the 4-week treatment period, the stapokibart group showed a 4.9-point reduction in daily rTNSS from baseline, with an LS mean difference of -1.7 points vs. placebo. The proportion of patients achieving mild or no nasal symptoms reached 84%. Sustained and significant improvement of ocular symptoms: Stapokibart demonstrated clinically significant reductions in the daily reflective Total Ocular Symptom Score (rTOSS) from baseline, with improvements of 2.6 points at week 2 and 3.7 points at week 4 respectively, both significantly superior to placebo. By Week 2, 62% of patients achieved mild or no ocular symptoms (defined as rTOSS ≤1 point for each symptom), increasing to 94% by Week 4. Significant reduction in levels of type 2 inflammatory biomarkers During the 4-week treatment period, the stapokibart group demonstrated significant reductions in total serum IgE levels and allergen-specific IgE (sIgE) levels against pollen allergens. Additionally, stapokibart reduced type 2 inflammatory biomarker levels in nasal secretions, including cystatin SN (CST1) and eotaxin-3, demonstrating its dual mechanism of action: targeting both the underlying etiology (type 2 inflammation) and symptomatic manifestations of allergic rhinitis. Safety Stapokibart demonstrated a favorable safety profile in patients with seasonal allergic rhinitis. The incidence of treatment-emergent adverse events (TEAEs) was comparable to placebo, and no serious adverse events (SAEs) were reported during the trial. The PHECDA trial pioneered targeted biologic therapy for allergic rhinitis. The results supported the approval of stapokibart—the world's first and only IL-4Rα monoclonal antibody for seasonal allergic rhinitis (SAR)— by China's National Medical Products Administration (NMPA) on February 7, 2025. This breakthrough provides a novel therapeutic option for patients with moderate-to-severe refractory SAR, solidifying Chinese clinical scientists' global leadership in allergic rhinitis research and setting a precedent for future clinical development. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, March 26, 2025 /PRNewswire/ -- March. 25, 2025, Keymed Biosciences Inc. (HKEX: 02162) announced its annual results of 2024, along with a corporate update. Rapid development of our pipeline products Stapokibart (CM310) (IL-4Rα antibody) Three new drug applications of Stapokibart for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyposis (CRSwNP) and seasonal allergic rhinitis have been approved by the NMPA. By the end of 2024, Stapokibart resisted strong sales and recorded revenue of approximately RMB40 million within three and a half months. In September 2024, the new drug application of Stapokibart injection for the treatment of moderate-to-severe atopic dermatitis in adults was approved by the NMPA. The phase III clinical study results indicated that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Additionally, the rates of achieving a weekly average reduction of ≥ 4 points from baseline in the daily PP-NRS score were 67.3% and 60.5%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In December 2024, the new drug application of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps was approved by the NMPA. The study results showed that the data from the Phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P < 0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. In February 2025, the new drug application of Stapokibart injection for the treatment of seasonal allergic rhinitis was approved by the NMPA. We advanced and completed the data unblinding and statistical analysis for the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR). The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing. The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits. Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety. In February 2024, we launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in adolescent subjects with moderate-to-severe AD. In May 2024, we initiated a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in subjects with nodular prurigo. As of the date of this announcement, the patient enrollment for this clinical study is in progress. In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart injection for the treatment of moderate-to-severe AD were presented by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. In October 2024, the full text of the 52-week efficacy and safety data of the Phase III clinical study was published in the《Allergy》, the top international journal in allergy and immunology field. CMG901/AZD0901 (Claudin 18.2 ADC) AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the indications of gastric cancer, pancreatic cancer and biliary tract cancer, including the Phase III clinical trial for 2L+ gastric cancer, Phase II clinical trial for 1L gastric cancer, Phase II clinical trial for 1L pancreatic cancer, and Phase II clinical trial for 2L+ biliary tract cancer. In June 2024, the data from the Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. On 6 January 2025, the data from the Phase I clinical study was released on the international authoritative oncology journal, The Lancet Oncology. The clinical data indicated that the median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months. CM313 (CD38 antibody) In 2024, we initiated and advanced a multi-center, open-label Phase I/II clinical study. In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. 95.5% of patients achieved a platelet count of ≥50 × 109/L within 8 weeks upon the first acceptance of CM313 infusion, and the durable platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6%. In July 2024, we completed Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with SLE. We plan to initiate a Phase II clinical study in the first half of 2025. In 2024, we initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313(SC) injection in subjects with primary immune thrombocytopenia. The first patient was enrolled and dosed in November 2024. We initiated a randomized, double-blinded, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313(SC) injection in subjects with IgA nephropathy in early 2025. As of the date of this announcement, preparations for patient enrollment are underway for this study. CM512 (TSLP x IL-13 bispecific antibody) We have initiated a randomized, double-blinded, single/multiple dose-escalation, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics and immunogenicity of CM512 in healthy subjects and patients with moderate-to-severe atopic dermatitis, with enrollment of the first subject completed in September 2024. The overseas Phase I clinical trial evaluating CM512 for the treatment of asthma was initiated in the first quarter of 2025. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a multi-center, open-label Phase I/II clinical study to assess CM336 injection in treating patients with relapsed or refractory multiple myeloma. As of the date of this announcement, the product is currently in the dose-expansion phase of Phase I/II clinical study. In December 2024, the latest data of the phase I/II clinical study of CM336 for relapsed or refractory multiple myeloma was presented as a poster at the 66th American Society of Hematology (ASH) Annual Meeting. CM383 (Aβ protofibrils antibody) As of the date of this announcement, the enrollment of all subjects in the Phase Ia clinical study of CM383 in healthy subjects was completed; In November 2024, the enrollment of the first subject in Phase Ib clinical study of CM383 in patients with mild cognitive dysfunction of Alzheimer's disease origin and mild Alzheimer's disease was completed. CM518D1 (CDH17 ADC) We submitted IND application to CDE, and planned to conduct a multi-center, open-label Phase I/II clinical trial for evaluation of CM518D1 in treatment of patients with advanced solid tumors. CM355/ICP-B02 (CD20 x CD3 bispecific antibody) We are conducting a Phase I/II clinical trial in China to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in r/r NHL. Dose escalation of the intravenous infusion formulation ("IV") was completed and the subcutaneous formulation ("SC") is being evaluated. Our preliminary data of both IV and SC formulations have shown good efficacy of CM355 in patients with follicular lymphoma ("FL") and DLBCL. CM350 (GPC3 x CD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study in 2024 to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. As of the date of this announcement, the product is currently in the dose-escalation of Phase I/II clinical study. CM369/ICP-B05 (CCR8 antibody) We are conducting a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed/refractory NHL. Dose escalation of CM369 has been escalated up to 450 mg in solid tumor and 600 mg in NHL, CM369 was well tolerated with no DLTs nor ≥grade3 TRAEs observed. The preliminary results demonstrated a favorable PK profile with sufficient exposure for target coverage and regulatory T-cell depletion. CM380 (GPRC5D×CD3 bispecific antibody) Preclinical studies indicated that CM380 had favorable antitumor effects and was well tolerated. As of the date of this announcement, we are planning to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively explore diversified BD models to maximize the global value of the pipeline. In July 2024, Chengdu Keymed entered into a license agreement with Belenos Biosciences,Inc. The license agreement grants Belenos the exclusive rights to develop, manufacture,and commercialize the Group's drug candidates CM512 and CM536 globally (excluding the Greater China region). In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments up to US$170 million. As of the date of this announcement, Belenos is planning to initiate a Phase I clinical trial evaluating CM512 for the treatment of asthma. In November 2024, Chengdu Keymed and Platina Medicines Ltd ("PML") entered into an exclusive license agreement. The license agreement grants PML the exclusive right to develop, manufacture and commercialize CM336 globally excluding Mainland China, Hong Kong, Macau and Taiwan. In return, the Group shall receive an upfront and near-term payment of US$16 million and a minority equity interest in Ouro Medicines, LLC ("Ouro Medicines") as part of the consideration. Ouro Medicines is the parent company of PML and owns 100% of the equity interest in PML. The Group may also receive additional payments of up to US$610 million subject to achievement of certain clinical, regulatory and commercial milestones and is also entitled to receive tiered royalties on net sales of CM336 and related products from PML. In January 2025, Chengdu Keymed entered into an exclusive out-license agreement with Timberlyne Therapeutics, Inc. The license agreement grants the target company the exclusive right to develop, manufacture and commercialize CM313 globally (excluding Mainland China, Hong Kong, Macau and Taiwan). In return, the Group shall receive an upfront and near-term payment of US$30 million and equity interest of the target company, being the largest shareholder of this company. The Group may also receive additional payments up to US$337.5 million subject to achievement of certain sales and development milestones. The Group is also entitled to receive tiered royalties on net sales from the target company. In January 2025, Chengdu Keymed, Beijing InnoCare and the Joint Venture have entered into the Agreement with Prolium for the development and commercialization of CM355. Under the terms of the Agreement, Prolium will have the exclusive right to develop, register, manufacture, and commercialize CM355 globally in non-oncology indications and in oncology indications outside of Asia. Rapid expansion of workforce and production facilities As of December 31, 2024, we had 1,300 full-time employees in total, including over 240 employees engaging in commercialization and nearly 400 employees engaging in drug discovery and clinical operations. We will continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. As of the date of this announcement, the production capacity of our production base has reached 20,000 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Financial highlights As of December 31, 2024, the Company generated a total annual revenue of RMB 430 million, representing a 21% year-on-year increase. This includes about RMB 40 million in sales revenue from Stapokibart over three and a half months and RMB 390 million in licensing revenue from BD agreements. Throughout 2024, the company continued advancing its differentiated pipeline development and clinical research, with R&D expenditures reaching approximately RMB 730 million, a 23% year-on-year increase. The company maintained a strong cash position with total cash on hand of approximately RMB 2.1 billion. Moving forward, Keymed will continue to establish, and refine its technology platforms, rapidly advancing the development of pipeline candidates in China and globally. The company will comprehensively drive the commercialization of approved product and indications. Concurrently, Keymed will proactively explore strategic partnerships worldwide to accelerate global patient access to its drug candidates through diversified BD models. The company plans to further recruit talent in commercial sales, clinical development, and manufacturing, expand cGMP-compliant production capacity, reduce costs, enhance operational efficiency, and remain committed to developing, producing, and commercializing innovative therapies that are globally competitive, high-quality, and affordable for patients worldwide. SOURCE Keymed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED